Jonathan W. Emord, Esq.

Supplement lawyer Jonathan Emord has filed three important suits this summer challenging FDA administrative action on first amendment grounds.  The suits were all filed on behalf of long-time Emord clients Durk Pearson, Sandy Shaw, the Alliance for Natural Health, and the Coalition to End FDA and FTC Censorship.

The complaints in all three cases were filed in federal district court for the District of Columbia and are captioned identically.  The first suit challenges the FDA’s rejection of qualified health claims for supplements containing the powerful antioxidant and anti-carcinogenic selenium (the “Selenium Challenge”).¹  A second suit challenges the FDA’s rejection of qualified health claims for antioxidant vitamins C and E (the “C and E Challenge”).² The third suit challenges the FDA’s dietary supplement current Good Manufacturing Practice regulations (the “cGMP Challenge”).³

These plaintiffs and their lawyer are well known for making law in the Pearson/Whitaker Cases that has benefitted the supplement industry significantly over the past ten years.⁴. Since the court decisions that may emerge from the new Selenium Challenge, C and E Challenge, and cGMP Challenge cases could have a significant impact on the law regulating supplement formulators, manufacturers, and marketers, and the FDA’s interpretations of that law, we are providing more expanded coverage here of these potentially important cases.  Part I will address the Selenium Challenge and the Vitamins C and E Challenge, and Part II will follow in a separate blog post to address the cGMP Challenge.

The Selenium Challenge and the Vitamin C and E Challenge – Does the FDA disregard the law and Supreme Court precedent by suppressing commercial speech about supplements?

For anyone not acquainted with the herculean legal struggle undertaken by Emord and his clients in the Pearson/Whitaker series of cases, the Complaint in the Selenium Challenge is a worthwhile read and I commend you to it.  The point of all the billable hours invested in this struggle may seem elusive but is actually quite simple: force the government to limit its censorship of claims about supplements to the “least restrictive means” test articulated again and again by the US Supreme Court in commercial speech cases.⁵

What does this mean from a practical standpoint for supplement companies?  It means that if you have a claim to make about your ingredient or formulation, and that claim is supported by competent and substantial scientific evidence, you should be allowed to make that claim as long as the claim is not deceptive or misleading. Sounds simple, right?  Sounds like the good practice you are already following for structure-function claims, right?

Well, what if that claim is a disease claim, like a claim that says “take this supplement and you may be able to prevent yourself from cancer.”   That’s not a DSHEA structure-function claim.  On the contrary, that’s the holy grail of supplement marketing, a claim that the FDA would say makes your product an unapproved drug and subjects you to prosecution for violation of the Food, Drug and Cosmetics Act.

Emord’s victories in the Pearson/Whitaker Cases paved the way for such claims, and required the FDA to create a new category of claims called “Qualified Health Claims.”  Qualified Health Claims are claims with disclaimers that provide a balanced view of the scientific evidence available to support a particular supplement’s impact on a specific disease state by incorporating a disclaimer that makes it clear to the consumer that the “jury is still out” on the ultimate conclusion suggested by the claim, but at the same time gives the consumer solid information to make critical purchase decisions.⁶

Fast forward several years to the emerging body of evidence developing around the powerful anti-carcinogenic effects of selenium.

Selenomethionine - an amino acid containing selenium.

This body of evidence shows significant correlation between selenium intake and the reduction in risk for certain cancers including cancers of the prostate, lung, respiratory tract, colon, and digestive tract.  Is the evidence conclusive?  No.  But is it powerful and supported by valid studies using recognized methods and conducted by reputable scientists?  Yes.

In reliance upon the body of evidence developed, Pearson and Shaw petitioned the FDA for approval of five qualified claims for selenium.⁷  Four out of the five claims were rejected outright.  A fifth claim, for prevention of prostate cancer, was saddled with disclaimers that were so onerous it was almost not worth making since the disclaimer was so long you could barely even fit it on the box or bottle with the supplement.

Some perspective is valuable here: FDA reviewed 233 studies in the course of its review of the challenged claims.  Pearson and Shaw submitted 77 studies as supportive of their claims.  According to the Selenium Challenge complaint, almost all the evidence submitted was ignored by FDA.  To their credit, Pearson and Shaw acknowledge that the evidence is not conclusive, but they do seem to have the weight of the credible scientific evidence on their side, much of which is detailed in the Selenium Challenge complaint complete with citations to the literature.

Pearson and Shaw also petitioned the FDA for approval of qualified claims for the antioxidant effects of Vitamins C and E.⁸  The claims consisted of ten Vitamin C qualified health claims and 7 Vitamin E qualified health claims involving the relationship between Vitamins C and E and the reduction in the risk for cancer. In support Pearson and Shaw submitted over 200 scientific publications demonstrating a nutrient-disease relationship between vitamins C and E and site-specific cancers.

Pearson and Shaw had hope that at least some of their claims might be approved.   However, in the interim, the FDA issued its guidance document, “Evidence-Based Review System for the Scientific Evaluation of Health Claims.” In this guidance document, according to the C and E Challenge, the FDA mucked up the analysis required for qualified claims by conflating it with the higher standard set for FDA Approved Claims. Once again, FDA rejected most of the proposed qualified claims, and for the ones that it accepted it rewrote them and included so much negatively laden verbiage as to make the claims unusable.

Both these challenges seek to reorient FDA thinking (to put it mildly) as it pertains to the qualified claims review system.  Emord clearly hopes that the D.C. Circuit will take FDA to task for its failure to comply with past decisions requiring it to lift excessive burdens on the free speech rights of supplement marketers so that consumers can be fully informed about developing science behind powerful dietary therapies available to treat and prevent disease.  We will see in Part II of this post how the new cGMP system also places burdens on the commercial speech rights of supplement makers, so stay tuned…

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1. Alliance for Natural Health US, Durk Pearson, Sandy Shaw, and the Coalition to End FDA and FTC Censorship v. Kathleen Sebelius, US Dept. of Health and Human Srvcs., Margaret M. Hamburg, M.D., FDA and USA, 1:09-cv-01470-ESH, Aug. 4, 2009, Huvelle, J.
2. Alliance for Natural Health US, Durk Pearson, Sandy Shaw, and the Coalition to End FDA and FTC Censorship v. Kathleen Sebelius, US Dept. of Health and Human Srvcs., Margaret M. Hamburg, M.D., FDA and USA, 1:09-cv-01546-RJL, Aug. 14, 2009, Leon, J.
3. Alliance for Natural Health US, Durk Pearson, Sandy Shaw, and the Coalition to End FDA and FTC Censorship v. Kathleen Sebelius, US Dept. of Health and Human Srvcs., Margaret M. Hamburg, M.D., FDA and USA, 1:09-cv-01523-CKK, Aug. 12, 2009, Kollar-Kotelly, J.
4. See, e.g., Pearson v. Shalala, 98-5043 (D.C. Cir. Jan. 15, 1999) and Whitaker v. Thompson, 03-5020 (D.C. Cir. Jan. 9, 2004)
5. See, Central Hudson Gas & Elec. v. Public Svc. Comm’n, 447 U.S. 557 (1980)
6. See Guidance for Industry: FDA’s Implementation of “Qualified Health Claims”: Questions and Answers; Final Guidance  (29 August 2009)
7. Selenium and a Reduced Risk of Site-specific Cancers, FDA-2008-Q-0323
8. Petition for Qualified Health Claims: Antioxidant Vitamins C and E and Reduction in the Risk of Site-Specific Cancers, FDA-2008-Q-0299

After an FDA warning letter told True Renewal to either register its products with the agency or change claims on its Web sites, the supplement maker has altered product descriptions. The FDA targeted five products, saying the Web sites claimed the items could be used to cure, treat or prevent disease.

Product descriptions on the Web site now differ from the FDA citations. For one product, Miracle Mineral Supplement, the FDA said that True Renewal claimed, “Hundreds of lives have been saved. Reports of overcoming incurable diseases are happening every day.”  The product page for the supplement now reads in part, “Any information provided herein is for educational purposes only and is NOT meant to diagnose, treat, cure or prevent disease.” The home page for Miracle Mineral Supplement also has this disclaimer: “The Miracle Mineral Supplement is not FDA approved and is not intended for human consumption.”

Similarly, the FDA said the company had claimed that Graviola contained compounds “that are 10,000 times stronger than chemotherapy and act only on cancer cells, not healthy cells!” Now, the Web page for Graviola lists ingredients, contraindications and drug interactions.

True Renewal is based in Provo, Utah. Three Web pages providing company and contact information list street and e-mail addresses, and a fax number. The FDA addressed its warning to Jenine M. Cohoon. According to one biography, she holds a Ph.D. in holistic nutrition. Her Web site, which the FDA cited in its letter, now has no content and points to True Renewal.

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Acai Palm

The acai berry has been credited by supplement companies with fighting cancer and other diseases.  The acai berry comes from the acai palm.

According to Steve Cox, BBB spokesperson, “many businesses across the country are using the same selling model for their acai products: they lure customers in with celebrity endorsements and free trial offers, and then lock them in by making it extremely difficult to cancel the automatic delivery of more acai products every month.” To read the press release, click here

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Although Section 403(y) of the Federal Food, Drug, and Cosmetic Act (FFD&C Act) (21 U.S.C. 343(y), does not require a dietary supplement label to include anything other than a domestic address or phone number for the responsible person, the FDA recommends that the label also bear a clear, prominent statement informing consumers that the domestic address or phone number is for reporting serious adverse events associated with use of the product.

Under section 3(d)(2) of the Dietary Supplement and Nonprescription Drug Consumer Protection Act, the labeling requirements of section 403(y) ofthe FFD&C Act apply to all dietary supplements labeled on or after December 22, 2007. Therefore, these labeling requirements are already in effect. However, FDA intends to exercise enforcement discretion for the new labeling requirements until January 1, 2010.

FDA would have no objection to a firm’s combining the recommended statement with language informing consumers that the domestic address or phone number on the label may also be used for other purposes, as long as the information provided is not false or misleading. For example, a dual-purpose label statement might be “To report a serious adverse event or obtain product information, contact. .. ” or other similar language.

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According to this article in Natural Products Insider, AHPA sent the inquiry following the launch of an “analgesic phytosterol supplement”, Bayer Aspirin with Heart Advantage, by Bayer Healthcare; the product combines 81 mg of aspirin and 400 mg of sterols, and carries both OTC drug and dietary supplement labeling and claims.

In its May 29 letter, AHPA cited two past warning letters from FDA issued to companies marketing OTC-supplement combination products without first filing new drug applications. AHPA also referenced this 2000 letter from FDA in which the agency “strongly” recommended companies not to market such products, given possible health and policy issues.

To read the AHPA press release on this, click here.

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“The challenges facing small to medium sized supplement firms are significant and growing,” said Joel Rothman, President of NutriCompliance. “New regulatory requirements for adverse event reporting (AER) and good manufacturing practices (GMP) are forcing supplement firms to take on new and greater responsibilities they may not have the resources internally to manage. NutriCompliance helps small to medium sized companies “bridge the gap” and meet the demands of today’s expanded regulatory environment.”

Annunziata is a supplement industry veteran whose regulatory experience includes work for industry giants like Life Extension Foundation and Jarrow Formulas. “NutriCompliance provides a platform for us to serve the needs of small to medium sized supplement companies to help solve their regulatory challenges,” said Annunziata. “Whether it is FDA compliance, FTC review, or any other regulatory issue, NutriCompliance has the experience and strength to assist its clients to successfully address these challenges.”

Based in Boca Raton, Florida, NutriCompliance serves nutritional and dietary supplement companies with vitamin, mineral, herbal, homeopathic, and proprietary blend products throughout the state and the nation. For more information on the services provided by NutriCompliance, please contact info@nutricompliance.com or call 561-416-0170.

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It appears that the school district’s position is that when Andrew took the supplements he violated his responsibility, set forth in the Boiling Springs Student Handbook, not to use drugs or alcohol. This incurs a 10 day suspension, but the school is also supposed to make sure Andrew “receive[s] appropriate support and education about the use of drugs and alcohol; receive[s] support from school nurse, guidance counselors, and Student Assistance Team in dealing with these issues if necessary.”

Not surprisingly, Andrew’s parents are boiling mad (pardon the pun), and have appealed the suspension. Andrew even took a drug test to assuage concerns that the supplements he took were really steroids. And, of course, they have a lawyer.

One of the comments posted to The Sentinel article astutely observes that since dietary supplements are regulated as a food, not a drug, in order to be consistent the school board will need to ban the consumption of food during lunch.  Perhaps we can convince the school that the appropriate support and education about the use of dietary supplements should be to read this blog.

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The principal focus of the piece is Chris Kilham a/k/a “The Medicine Hunter” (pictured right), whose business is “to promote natural, plant-based medicines, to protect the natural environment, and to support indigenous cultures.”
The article tells the story of the complex relationship between this traditional herbal “cure,” the indigenous people whose livelihoods depend upon it, and the western companies that profit from it.

Make sure to view the interactive multimedia presentation that complements the article in the Times.

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FDA held a 3 hour webcast last week detailing its industry guidance on the new CGMP regulations. The webcast has been archived. To view the webcast at your leisure click here.

FDA suggests using Internet Explorer to allow full navigation through the webcast.

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If successful, this will be the second contempt order entered against Trudeau. Trudeau has had several run-ins with the FTC, as detailed in the case filings archived at the FTC website.

This latest Trudeau incident provides some insight into the intersection of supplement marketing practices and the first amendment. The FTC could not, consistent with the First Amendment, prevent Trudeau from writing about whatever he chose in his books. However, the FTC can, and has, enjoined Trudeau from making unfair and deceptive claims about what he writes in those books, including, as in this instance, claims that a weight loss plan is “easy” when it actually involves eating a 500 calorie starvation diet combined with daily injections of a prescription drug banned in the U.S.

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